MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-10 for ALCON POSTERIOR CHAMBER INTRAOCULAR LENS MZ 60 BD manufactured by Alcon Surgical Inc.
[20768013]
Doctor noted haptic on i. O. L was cracked after it was implanted in patients left eye. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure, telemetry failure, unanticipated short term complication of procedure, invalid data. Conclusion: device failure occurred and was related to event, device was out of spec in a manner that relates to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3724 |
| MDR Report Key | 3724 |
| Date Received | 1992-07-10 |
| Date of Report | 1992-03-30 |
| Date of Event | 1992-02-25 |
| Date Facility Aware | 1992-02-25 |
| Report Date | 1992-03-30 |
| Date Reported to Mfgr | 1992-02-28 |
| Date Added to Maude | 1993-05-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALCON POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic Name | POSTERIOR CHAMBER LENS |
| Product Code | HQH |
| Date Received | 1992-07-10 |
| Model Number | MZ 60 BD |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | 21.5 POWER |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3470 |
| Manufacturer | ALCON SURGICAL INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-10 |